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Notice of the making of this Statutory Instrument was published in
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"Iris Oifigiúil" of 6th January, 2015.
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I, LEO VARADKAR, Minister for Health, in exercise of the powers conferred on me by sections 13 and 32 (as amended by sections 15 and 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995) and section 29 of the Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14 of 2013), hereby make the following Regulations:
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1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2014.
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2. In these Regulations-
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"Act" means the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 ( S.I. No. 444 of 2001 ), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 ( S.I. No. 576 of 2002 ), the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006), the European Communities (Amendment of the Medicines Board Act 1995) Regulations 2007 ( S.I. No. 542 of 2007 ) and section 36 of the Health (Pricing and Supply of Medical Goods) Act 2013 ;
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"active substances register" means the register of importers, manufacturers and distributors of active substances maintained by the Authority in pursuance of Regulation 14D of the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013;
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"Authority" means the Health Products Regulatory Authority established by section 3 of the Act;
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"broker" means a person carrying out the brokering of medicinal products, as defined in Regulation 4(1) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013;
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"brokers register" means the register maintained by the Authority in pursuance of Regulation 14D of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013;
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"certificate of free sale" means a certificate of free sale issued under section 4(1)(k)(ii) of the Act;
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"certificate of registration" means a certificate of registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;
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"certificate of traditional-use registration" means a certificate of traditional-use registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014 in respect of a traditional herbal medicinal product;
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"certification of documents" means the certification, under section 4(1)(k)(ii) of the Act, of documents not being certificates of free sale or export certificates;
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"complex dossier" refers to an application accompanied by a full dossier in accordance with Directive 2001/83/EC;
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"decentralised procedure" means the decentralised procedure for human medicinal products provided for in Directive 2001/83/EC;
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"Directive 2001/83/EC" means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 , as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 20032 , Commission Directive 2003/63/EC of 25 June 20033 , Directive 2004/24/EC of the European Parliament and of the Council of 31 March 20044 , Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20045 , Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 20066 , Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 20077 , Directive 2008/29/EC of the European Parliament and of the Council of 11 March 20088 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 20099 , Commission Directive 2009/120/EC of 14 September 200910 , Directive 2010/84/EU of the European Parliament and of the Council of 15 December 201011 , Directive 2011/62/EU of the European Parliament and of the Council of 8 June 201112 and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 201213 ;
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"export certificate" means a certificate issued under section 4(1)(k)(ii) of the Act;
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"follow-up inspections" means inspections other than routine inspections;
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"homeopathic medicinal product" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;
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"individual authorisation" means an authorisation granted to an individual under Part 8 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 ( S.I. No. 543 of 2012 );
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"interchangeable medicinal product" means a medicinal product which falls within a group of interchangeable medicinal products pursuant to the Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14 of 2013);
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"manufacturer’s authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013;
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"marketing authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;
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"mutual recognition procedure" means the mutual recognition procedure for human medicinal products provided for in Directive 2001/83/EC;
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"national rules scheme" means the national rules governing the granting of marketing authorisation in respect of homeopathic medicinal products, as provided in Regulation 11 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 );
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"organ establishment authorisation" means an authorisation granted pursuant to the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 and 2014;
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"parallel import licence" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;
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"project" means a programme of work having a defined scientific objective and involving one or more procedures pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2014;
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"project authorisation" means an authorisation granted under Part 5 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012;
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"reduced dossier - complex" refers to an application for a generic medicinal product accompanied by a reduced dossier but containing additional data in circumstances required by Directive 2001/83/EC;
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"reduced dossier - standard" refers to an application for a generic medicinal product accompanied by a reduced dossier in accordance with Directive 2001/83/EC;
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"service item" means an application for a medicinal product designated by the Board as qualifying for a reduced application fee on the basis that the product has limited but important uses for which no alternative authorised product exists;
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"subsequent extension applications" means applications in relation to additional pharmaceutical forms and strengths of a medicinal product, made subsequent to the first application in relation to that product;
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"switching applications" means applications for a change in the classification of medicinal products under Title VI of Directive 2001/83/EC;
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"traditional herbal medicinal product" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;
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"type IA variation", "type IB variation" and "type II standard variation" shall be classified by the Board in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 200814 , as amended by Commission Regulation (EU) No. 712/2012 of 3 August 201215 ;
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"wholesaler’s authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013.
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3. Subject to Regulation 4, there shall be paid to the Board in respect of each and every matter set out in column 1 of the Schedule the fee as set out in column 2 of the Schedule.
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4. The Board may, in circumstances where it considers it appropriate to do so, waive, remit or refund, either in whole or in part, any fee that would otherwise be payable to it under Regulation 3.
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5. The Irish Medicines Board (Fees) Regulations 2013 ( S.I. No. 501 of 2013 ) are revoked.
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SCHEDULE
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COLUMN 1
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COLUMN 2
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Fees for national applications for marketing authorisations
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€
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Complex dossier
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National application
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15,211
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Reduced dossier - complex
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National application
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11,329
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Reduced dossier - standard
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National application
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7,658
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Subsequent extension applications
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First additional form
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7,658
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Each additional form (same time)
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5,090
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First additional strength (existing form)
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2,756
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure
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Complex dossier
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Mutual recognition incoming
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10,647
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Each additional form (same time)
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3,660
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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10,962
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Decentralised incoming
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15,211
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Decentralised outgoing
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40,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional supplement where there are 15 or more concerned Member States
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1,000
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Reduced dossier - complex
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Mutual recognition incoming
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8,077
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Each additional form (same time)
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3,251
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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10,962
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Decentralised incoming
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11,329
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Decentralised outgoing
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30,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional supplement where there are 15 or more concerned Member States
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1,000
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Reduced dossier - standard
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Mutual recognition incoming
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5,350
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Each additional form (same time)
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2,859
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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7,126
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Decentralised incoming
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7,658
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Decentralised outgoing
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20,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional supplement where there are 15 or more concerned Member States
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1,000
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Subsequent extension applications
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Mutual recognition incoming (first additional form)
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5,350
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Mutual recognition incoming (first additional strength)
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1,929
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Mutual recognition incoming (subsequent additional strength)
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656
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Outgoing mutual recognition/decentralised supplement (additional form)
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2,859
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Outgoing mutual recognition/decentralised supplement (additional strength)
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656
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Decentralised incoming (first additional form)
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7,658
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Decentralised outgoing (first additional form)
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20,000
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Each additional form (same time)
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5,090
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First additional strength (existing form)
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2,756
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Each additional strength (same time)
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656
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Additional supplement where there are 15 or more concerned Member States
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1,000
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Switching applications
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Switching applications
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5,000
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Fees for parallel import licences
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Application fee - per country at the same time or by variation
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1,662
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Each additional strength per country
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495
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Each additional form per country
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495
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Parallel imports of dual pack registrations
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831
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Registration of parallel imports - each additional strength or form
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495
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Parallel imports where the originator is not on the Irish market
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5,000
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Change of ownership per product range
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525
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Fees for variations to national marketing authorisations
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Type IA variation
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100
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Type IB variation
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468
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Type IB variation - reduced rate
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234
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Type II complex variation
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2,601
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Type II standard variation
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506
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Type II standard variation - reduced rate
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253
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Notifications under Article 61(3) of Directive 2001/83/EC
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250
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Notifications under Article 61(3) of Directive 2001/83/EC - reduced rate
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125
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Multiple variations capped fee (per product range)
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5,200
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Multiple variations capped fee (per product)
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3,400
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Worksharing capped fee
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5,200
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Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure
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Type IA variation - mutual recognition incoming
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100
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Type IB variation outgoing mutual recognition / decentralised supplement
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345
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Type IB variation - mutual recognition incoming
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338
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Type IB variation - mutual recognition incoming - reduced rate
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174
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Type II complex variation - outgoing mutual recognition / decentralised supplement
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525
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Type II complex variation - mutual recognition incoming
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1,797
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Type II standard variation - mutual recognition incoming
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338
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Type II standard variation - mutual recognition incoming - reduced rate
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174
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Type II standard variation - outgoing mutual recognition / decentralised supplement
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338
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Notifications made under Article 61(3) of Directive 2001/83/EC
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250
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Notifications made under Article 61(3) of Directive 2001/83/EC - reduced rate
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125
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Fees for the granting of a marketing authorisation on transfer to another company
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Change of ownership - related company - 1st marketing authorisation within a range
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900
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Change of ownership - related company - additional marketing authorisations within a range
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321
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Change of ownership - non-related company - 1st marketing authorisation within a range
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1,316
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Change of ownership - non-related company - additional marketing authorisations within a range
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321
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Other fees relating to the granting of marketing authorisations
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Service item
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612
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Interchangeable medicinal products
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Application Fee - addition of product to a group of interchangeable products or addition of group of products to the list of interchangeable products
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500
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Fees for applications for wholesaler’s authorisations
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Application fee
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555
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Variation to authorisation - minor site technical
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400
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Variation to authorisations - administrative
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219
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Variation to authorisation - technical
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603
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Fees for applications for manufacturer’s authorisations
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Application fee
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1,853
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Variation to authorisation - administrative
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274
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Variation to authorisation - technical
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768
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Fees for applications in relation to brokers register and active substances register
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Registration fee
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250
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Immediate notification of a change which may impact on the quality or safety of the active substances
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768
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Notification of an administrative change to the active substances register
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136
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Notification of any change to the brokers register
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136
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Fees for applications for organ establishment authorisations
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Application charge
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1,853
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Variation to authorisation - administrative
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274
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Variation to authorisation - technical
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768
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Appeal to amend/revoke an authorisation
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500
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Fees for transferring of authorisation/registration to another company
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Manufacturer’s authorisation and organ establishment authorisation
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Related companies
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1,107
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Unrelated companies
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1,853
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Wholesaler’s authorisation, registration on brokers register and registration on active substances register
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Related companies
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365
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Unrelated companies
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555
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Fees for applications in relation to medical devices and cosmetic products
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Certificates of free sale - standard (4 certs per request)
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147
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Certificates of free sale - fast track (4 certs per request)
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277
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Duplicate certificates of free sale - each (available at time of initial request)
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23
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Fees for applications in relation to homeopathic medicinal products
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New national / decentralised registration standard charge - single stock
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678
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New national / decentralised registration standard charge - 2 or more stocks
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1,016
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New application - national rules scheme standard fee - single stock
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1,016
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New application - national rules scheme standard fee - 2 or more stocks
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1,500
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Mutual recognition incoming application standard fee - single stock
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452
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Mutual recognition incoming application standard fee - 2 or more stocks
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678
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Outgoing mutual recognition / decentralised supplement
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564
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National variation - registration and national rules scheme
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339
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National variation - reduced rate - registrations and national rules scheme
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170
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Mutual recognition incoming variation
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226
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Mutual recognition incoming variation - reduced rate
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113
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Variation - outgoing mutual recognition / decentralised supplement
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170
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Bulk variation for multiple changes to the masterfile
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2,038
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Fees for applications in relation to traditional herbal medicinal products
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National applications for certificates of traditional-use registration
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National application
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4,888
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National application where there is a monograph
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3,000
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Each additional form (same time)
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4,072
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Each additional strength (same time)
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525
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Additional drug master file submitted
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3,251
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Extension applications
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First additional form
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4,888
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Each additional form (same time)
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4,072
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First additional strength
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2,205
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Each additional strength (same time)
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525
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Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure
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Mutual recognition incoming
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3,418
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Mutual recognition incoming - each additional form (same time)
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2,287
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Mutual recognition incoming - each additional strength (same time)
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525
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Outgoing mutual recognition / decentralised supplement
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4,445
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Decentralised outgoing/incoming
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4,888
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Each additional form (same time)
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4,072
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Each additional strength (same time)
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525
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Traditional herbal medicinal products - national variations
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Type IB variation - national
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375
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Type IB variation - reduced rate
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190
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Type II standard variation
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400
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Type II standard variation - reduced rate
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200
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Type II complex variation
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2,100
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Bulk variation for multiple changes
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4,200
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Traditional herbal medicinal products - mutual recognition variations
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Type IB variation - mutual recognition incoming
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270
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Type IB variation - mutual recognition incoming - reduced rate
|
140
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Type IB variation - outgoing mutual recognition supplement
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275
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|
Type II standard - mutual recognition incoming
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270
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Type II standard - mutual recognition incoming - reduced rate
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140
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Type II standard - outgoing mutual recognition supplement
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270
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Type II complex - mutual recognition incoming
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1,435
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Type II complex - outgoing mutual recognition supplement
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420
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Fees for export certificates and certification of documents
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Standard
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147
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Fast track
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277
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Annual maintenance fees
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Marketing authorisations and registrations
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First 10 marketing authorisations
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650
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Additional marketing authorisations
|
812
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|
Dormant marketing authorisations
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420
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|
Parallel import registration
|
113
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|
Dual pack registration
|
55
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|
Homeopathic medicinal products
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55
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|
Traditional herbal medicinal products
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113
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|
Manufacturer’s authorisations
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|
Major site (more than 250 employees)
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16,669
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Large site (150-250 employees)
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11,112
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Medium site (50-149 employees)
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7,409
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Small site (less than 50 employees)
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3,703
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Wholesaler’s authorisations
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Large full line
|
2,771
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Medium full line/ short line
|
1,576
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Small short line
|
600
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Minor site
|
400
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Procure and supply only
|
350
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Active substances register
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Active substances distributor
|
250
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Active substances importer
|
500
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Active substances manufacturer
|
1,000
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|
Organ establishment authorisations
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Major establishment (more than 250 employees)
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16,669
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Large establishment (150-250 employees)
|
11,112
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|
Medium establishment (50-149 employees)
|
7,409
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Small establishment (less than 50 employees)
|
3,703
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|
Project fees
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|
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Project application without ethical approval
|
2,000
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Fast track project application
|
2,000
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Establishment fees
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Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders
|
250
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Band 2: Establishment with 4-10 individual authorisation holders
|
500
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Band 3: Establishment with 11-20 individual authorisation holders
|
750
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Band 4: Establishment with 21-50 individual authorisation holders
|
1,500
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Band 5: Establishment with 51-100 individual authorisation holders
|
3,000
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Band 6: Establishment with 101-150 individual authorisation holders
|
5,000
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|
Band 7: Establishment with 151-200 individual authorisation holders
|
7,500
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Band 8: Establishment with >201 individual authorisation holders
|
10,000
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Individual authorisation fees
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Application fee
|
150
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|
Annual fee
|
150
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Once-off authorisation - procedural training for a period of two weeks or less (reduced fee)
|
50
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|
Fees for follow-up inspections
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Per day (per member of the inspection team)
|
1,489
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Part of day (per hour, per member of the inspection team)
|
213
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Inspection fees (other than inspections in relation to the protection of animals used for scientific purposes)
|
|
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Per day (per member of the inspection team)
|
1,489
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|
Part of day (per hour, per member of the inspection team)
|
213
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Enforcement fees
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|
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Manufacturers
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Major site (more than 250 employees)
|
2,400
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Large site (150-250 employees)
|
1,800
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Medium site (50-149 employees)
|
600
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Small site (less than 50 employees)
|
200
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Wholesalers
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Large full line
|
600
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|
Medium full line / short line
|
200
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|
Marketing authorisation / parallel import licence holders
|
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> 50 marketing authorisations / parallel import licences
|
3,150
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31-50 marketing authorisations / parallel import licences
|
1,000
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16-30 marketing authorisations / parallel import licences
|
600
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|
6-15 marketing authorisations / parallel import licences
|
200
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(Note: Companies classed as both manufacturer and wholesaler are charged the higher of the two applicable charges. Marketing authorisation holders pay the marketing authorisation holder fee in addition to any manufacturer / wholesaler fee.)
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GIVEN under my Official Seal,
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23 December 2014.
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LEO VARADKAR,
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Minister for Health.
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EXPLANATORY NOTE
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(This note is not part of the instrument and does not purport to be a legal instrument.)
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The purpose of these Regulations is to provide for the revision of fees payable to the Health Products Regulatory Authority (formerly the Irish Medicines Board) pursuant to Section 13 of the Irish Medicines Board Act 1995 and section 29 of the Health (Pricing and Supply of Medical Goods) Act 2013 .
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These Regulations revoke the Irish Medicines Board (Fees) Regulations 2013 ( S.I. No. 501 of 2013 ).
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1 OJ No. L 311, 28.11.2001, p. 67.
2 OJ No. L 33, 8.2.2003, p. 30.
3 OJ No. L 159, 27.6.2003, p. 46.
4 OJ No. L 136, 30.4.2004, p. 85.
5 OJ No. L 136, 30.4.2004, p. 34.
6 OJ No. L 378, 27.12.2006, p. 1.
7 OJ No. L 324, 10.12.2007, p. 121.
8 OJ No. L 81, 20.3.2008, p. 51.
9 OJ No. L 168, 30.6.2009, p. 33.
10 OJ No. L 242, 15.9.2009, p. 3.
11 OJ No. L 348, 31.12.2010, p. 74.
12 OJ No. L 174, 1.7.2011, p. 74.
13 OJ No. L 299, 27.10.2012, p. 1.
14 OJ No. L 334, 12.12.2008, p. 7.
15 OJ No. L 209, 4.8.2012, p. 4.
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